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FDA Lifts Clinical Hold on Concert Pharmaceuticals Clinical Trial with CTP-543

LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it has lifted the clinical hold on Concert’s CTP-543 Phase 2a clinical trial for alopecia areata. The Company will amend the protocol for the Phase 2a trial to evaluate two doses of CTP-543, each for a 24 week duration. Concert will resume enrollment in the Phase 2a trial later this month and expects to complete the trial in the second half of 2018.

“We believe the FDA is taking a measured approach for the development of Janus kinases inhibitors, or JAK inhibitors, for autoimmune dermatological disorders, including alopecia areata. Accordingly, we agreed to modify the design of our Phase 2a trial to evaluate CTP-543 in the patient population in a more step-wise fashion. It is important to note that CTP-543 has been well-tolerated in clinical evaluation to date and demonstrates a non-clinical safety profile consistent with JAK inhibition,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “Alopecia areata is an autoimmune disease for which there is a significant unmet medical need with no FDA-approved therapy, and we intend to be at the forefront of advancing a new oral treatment for alopecia areata patients.”

The Phase 2a trial is a double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of CTP-543 in adults with moderate-to-severe alopecia areata. Approximately 90 patients will be enrolled in the study and will be sequentially randomized to receive one of two doses of CTP-543 (4 and 8 mg twice daily) or placebo. The primary outcome measure will utilize the severity of alopecia tool (SALT) after 24 weeks of dosing. If appropriate, the protocol may be amended to explore higher doses of CTP-543. Additional information about the trial is available on www.clinicaltrials.gov.

In May 2017, the FDA informed the Company that a review of certain non-clinical toxicology studies was required before proceeding with dosing in the Phase 2a...


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